Trial Outcomes & Findings for A Phase 2 Study of Tarceva for Untreated, Good Prognosis Patients With Advanced Non-Small Cell Lung Cancer (NCT NCT00585533)

Results Overview

Will determine if 6-month chemotherapy-progression-free (CP-free) survival rate (using RECIST) is significantly higher than the historically observed 31%. A one-sided binomial test at a 5% nominal significance was used.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

40 participants

Primary outcome timeframe

6 months

Results posted on

2013-07-30

Participant Flow

Participant milestones

Participant milestones
Measure	All Participants All participants enrolled in trial.
Overall Study STARTED	40
Overall Study COMPLETED	31
Overall Study NOT COMPLETED	9

Reasons for withdrawal

Reasons for withdrawal
Measure	All Participants All participants enrolled in trial.
Overall Study objective or symptomatic progression	9

Baseline Characteristics

A Phase 2 Study of Tarceva for Untreated, Good Prognosis Patients With Advanced Non-Small Cell Lung Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	All Participants n=40 Participants All participants enrolled in trial.
Age, Categorical <=18 years	0 Participants n=99 Participants
Age, Categorical Between 18 and 65 years	10 Participants n=99 Participants
Age, Categorical >=65 years	30 Participants n=99 Participants
Age Continuous	65 years STANDARD_DEVIATION 10.09443 • n=99 Participants
Sex: Female, Male Female	15 Participants n=99 Participants
Sex: Female, Male Male	25 Participants n=99 Participants
Region of Enrollment United States	40 participants n=99 Participants

PRIMARY outcome

Timeframe: 6 months

Will determine if 6-month chemotherapy-progression-free (CP-free) survival rate (using RECIST) is significantly higher than the historically observed 31%. A one-sided binomial test at a 5% nominal significance was used.

Outcome measures

Outcome measures
Measure	All Participants n=40 Participants All participants enrolled in trial.
Survival Rate at 6-months Chemotherapy-progression-free (CP-free)	55 percentage of participants Interval 27.7 to 28.8

SECONDARY outcome

Timeframe: 24 months

Estimated via a Kaplan-Meier curves. Survival will be counted from the first dose of Tarceva.

Outcome measures

Outcome measures
Measure	All Participants n=40 Participants All participants enrolled in trial.
Overall Survival	50.1 weeks Interval 48.5 to 51.7

Adverse Events

All Participants

Serious events: 0 serious events

Other events: 9 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	All Participants n=40 participants at risk All participants enrolled in trial.
Skin and subcutaneous tissue disorders Rash	7.5% 3/40 • Number of events 3
Gastrointestinal disorders Diarrhea	5.0% 2/40 • Number of events 2
General disorders Deep Vein Thrombosis	2.5% 1/40 • Number of events 1
Skin and subcutaneous tissue disorders Paronychia	5.0% 2/40 • Number of events 2
Metabolism and nutrition disorders Mucositis	2.5% 1/40 • Number of events 1

Additional Information

Wallace Akerley, MD

Huntsman Cancer Institute/University of Utah

Phone: 801-585-5986

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place